HEB - Hemispherx BioPharma

[FreshlyBlended]

A FDA decision on HEB's Ampligen was originally expected by February 25, 2009, for the Company's submission of its Ampligen(r) NDA, which is designated as an Orphan Drug for the treatment of Chronic Fatigue Syndrome, which has no FDA approved treatments on the market. Ampligen(r) is also authorized for Emergency (compassionate) Cost Recovery Sales Authorization by the FDA and has a "promising" designation by the Agency on Health Research Quality (AHRQ): "Ampligen(r), an investigational drug that is not approved by the FDA, given intravenously to severely debilitated patients, yielded the most promising results." The extended user fee goal date is now May 25th, 2009.

May 26, 2009 Hemispherx Biopharma Announces Possible Brief Delay
The U.S. Food and Drug administration ("FDA") has advised the company that it may require up to 1-2 additional weeks

Now that the 1-2 weeks have past the company is now in a "limbo" state. We are waiting for the FDA decision on Ampligen and do not know when it will come. According to FDA statistics and the CEO Dr. Carter in a conference call Ampligen has a 80% chance of approval. It might be closer to 90% since this is a drug for which no other treatments exist. So the FDA wont be denying this drug because something works better, there is nothing else

Ampligen appears to be safe and effective. Here is a great article that separates the fact from fiction.

Hemispherx BioPharma
One Penn Center
1617 JFK Blvd., 6th Floor
Philadelphia, PA 19103
Phone: (215) 988-0080
Fax: (215) 988-1739

Hemispherx Biopharma, Inc. -- Research & Development: Welcome to our Website
Ampligen - Wikipedia, the free encyclopedia

[FavStocks]

Swine flu fears hit Wimbledon tournament

* Story Highlights
* Twenty-eight Wimbledon staff told to stay at home amid swine flu fears
* Newspaper reports says two players are suspected to have swine flu

updated 12:18 p.m. EDT, Wed July 1, 2009

LONDON, England (CNN) -- A total of 28 staff at the Wimbledon Tennis Championships have been asked to stay at home with suspected swine flu.
28 Wimbledon staff are reported to have suspected swine flu.

28 Wimbledon staff are reported to have suspected swine flu.

It was reported Wednesday that two players competing at the tournament are believed to have contracted the virus.

According to the UK's Daily Mail newspaper, the players are world number 29 doubles player Michal Mertinak and his fellow Slovakian world number 22 Filip Polasek.

Both are already out of the tournament. The paper reported that Mertinak pulled out of the mixed doubles because he was feeling unwell.

A spokeswoman for the the tournament's organizers, the All England Lawn Tennis Club, told CNN she could not comment on the players said to be affected with the virus.

She added that the number of suspected cases of swine flu among Wimbledon staff was no higher than the incidence rate in London as a whole.

The spokeswoman said: "In total, 28 people have been asked to stay home. Our medical officers advise any staff with flu-like symptoms to stay at home until they're better.

"They can back if they are free of symptoms for at least 24 hours and if they feel up to it."

Earlier this week, tournament organizers sent a letter to all competitors, advising them to take precautions against the virus after four ball boys and girls showed flu-like symptoms. Three of those are now back at Wimbledon.

The tournament organizers advised players to wash their hands after using the computers in the players' lounge, to cover their mouths after sneezing and not to re-use towels.

[Bkw0957]

Looks like we will not hear from the FDA today.They have already posted approvals for today.

[FreshlyBlended]

If you have not seen this already I reccomend you check this out

Slides of Ampligen® Trial Results Used in Presentation at IACFS/ME Conference March 19, 2009


The safety and efficiency data from those side look really great. I am extremely confident in HEB.

[FavStocks]

Looks like we will not hear from the FDA today.They have already posted approvals for today.

Not much work will get done today IMO since Friday is a holiday. FDA probably already left for the day to get an early start on the weekend

[Bkw0957]

I agree. This was posted by noon. Probably a half day.

[barkmandog]

The six month chart on heb looks like ctic. Wish I would have seen this in Feb when it was .37 cents.

[fortune419]

SPPI heard from the FDA practically on time. I know it is was just a labeling extension. The HEB delay is not over a month. How long can the FDA keep a company in limbo before any type of communication?

[Bkw0957]

I guess as long as they want.

[Tessa]

SPPI heard from the FDA practically on time. I know it is was just a labeling extension. The HEB delay is not over a month. How long can the FDA keep a company in limbo before any type of communication?

Just some thoughts.
The way I understand it, FDA has a group for each item they have to make a decision on. Some of the members in each group can be scientists, doctors, etc. The HEB group is having staffing issues, which could mean that one or more of the staff (group) members is unavailable to work on it at this time. Not sure if they have to start over on their assessment of Ampligen if they have to change group members.